FDA Food Recalls

Recalls / Class II

Class IIF-2414-2015

Product

Kr8om Max2 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 2 tablets; Kr8om Max5 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 5 tablets; Kr8om Max10 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC. Fort Worth, TX 76112, 10 tablets; Tablets are packed in a round, clear plastic screw-on lid container. Dosage is "1 tablet after a meal", each tablet is "4.20 g Maeng Da leaf equiv".

Type
Food
Affected lot / code info
All products manfactured since 6/1/2011
Quantity
2,066 units

Why it was recalled

This products contain Kratom.

Recalling firm

Firm
Nuevotanicals
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
7001 E Lancaster Ave Ste 129, N/A, Fort Worth, Texas 76112-7268

Distribution

Distribution pattern
Alabama, Arizona, California, Florida, Illinois, Nevada, New York, Ohio, Oklahoma, Oregon, Texas, and Virginia.

Timeline

Recall initiated
2014-07-01
FDA classified
2015-06-08
Posted by FDA
2015-06-17
Terminated
2017-03-02
Status
Terminated

Source: openFDA Food Enforcement endpoint. Recall record F-2414-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings.